180O - Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: A multicenter, open-label, single-arm, phase II study

Background

Zimberelimab is a novel, fully human anti-PD-1 monoclonal antibody with high affinity and selectivity for PD-1. The objective of this study (NCT03972722) was to evaluate zimberelimab, a novel, anti-programmed cell death protein 1 monoclonal antibody, in patients with programmed death ligand-1-positive recurrent or metastatic cervical cancer that had progressed after first- or subsequent-line platinumcontaining standard chemotherapy.

Methods

In this single-arm, phase II study, eligible patients in 27 Chinese sites were assigned to receive intravenous zimberelimab 240 mg as monotherapy every 2 weeks until confirmed disease progression, death, intolerable adverse effects, or withdrawal from the study. The primary endpoint was the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors (version 1.1) by an independent review committee. Secondary endpoints included duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

Results

Ninety participants were included in the full analysis set, with a median follow-up of 11.5 months. Complete and partial responses were achieved by 4 and 21 patients, respectively, corresponding to an ORR of 27.8% (95% confidence interval [CI], 18.85 to 38.22; P < .0001 vs historical controls). Median OS and DoR were not reached during the study: 12-month OS rates were 54% (95% CI, 41 to 66) and 6-month DoR rates were 84% (95% CI, 58 to 95). Median PFS was 3.7 months and the 12-month PFS rate was 15% (95% CI, 2 to 42). Treatment-related adverse events (TRAEs) occurred in 78.1% of participants, with hypothyroidism (25.7%) and anemia (19.0%) being the most frequently reported. Grade ≥ 3 TRAEs occurred in 22.9% of participants.

Conclusions

Zimberelimab monotherapy demonstrated durable antitumor activity and an acceptable safety profile in patients with recurrent or metastatic cervical cancer that had progressed after first- or subsequent-line platinum-containing standard chemotherapy. Further investigation of zimberelimab in patients with cervical cancer is warranted.

Clinical trial identification

NCT03972722.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Guangzhou Gloria Biosciences Co., Ltd.

Disclosure

J. Zhu: Financial Interests, Personal, Sponsor/Funding: Guangzhou Gloria Biosciences Co., Ltd. All other authors have declared no conflicts of interest.